A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of an Inhaled Antibody in Healthy Volunteers

Phase 1

Completed

• Conditions: COVID-19; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12621001235897
• Lead Sponsor: Inhalon Biopharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Study Completion: 2021-12-29
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1.Male and female, age 18-55 years, inclusive.
2.Non-smoker or smokes on average less than or equal to 10 cigarettes per week
3.Woman participants must be non-pregnant and either surgically sterile, use an acceptable contraceptive method, or be post-menopausal
4.Male participants must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the partner must be surgically sterile or using an acceptable contraceptive method
5.Negative SARS-CoV-2 RT-PCR nasal swab during screening period

Exclusion Criteria

1.Known or suspected symptomatic viral infection within 14 days of dosing initiation.
2.Signs of active pulmonary infection or pulmonary inflammatory conditions within 14 days of dosing.
3.History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo.
4.History of previous administration of a monoclonal antibody or any inhaled biologic.
5.History of vaccination against SARS-CoV-2.
6.History of atopy or airway hyperresponsiveness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified